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VITAMIN POLICY

Keeping in view the minutes of the Pre-Board understanding meeting, held on 9th August, 2007 with the PPMA & Pharma Bureau in the committee room of Ministry of Health. Director General (Health), following recommendations were finalized: a) PPMA & Pharma Bureau collectively adopted a stand that vitamins shall remain under the Drugs Act, 1976. b) That the formulations approved by the Regulatory Authorities of the developed countries will remain register in the identical strengths of active ingredients with special focus on the optimum level of the Vitamin A, Vitamin D, Vitamin E and certain Trace Elements which exhibit toxicity because the dietary habits of Pakistan population are full of the Vitamins. It will be mandatory that free sale certificate would be submitted to the Ministry of Health for continuation of the formulation or new registrations identical. The formulations which were registered up to December, 1997 will also remain in the market. However, their ingredients strength levels will be rationalized at uniform formula. Rest of the formulations will be reviewed in the light of Para b & c. In case of formulations not in line with the b & c, the firms will be allowed to adopt similar formulations available in the light of the Para b & c or surrender the formulation. All the pending applications will be decided in the light of Para b & c. Mandatory stability studies along with validation of testing methods will be pre-requisite for the grant of registrations. Pricing issues will be decided by the PRC. The firms seeking manufacturing permission for minerals will be required to possess the facility of the atomic absorption. A committee comprising of two members each from PPMA & Pharma Bureau along with MOH will scrutinize the pending applications in the light of above recommendation in the light of Para b & c. This committee would submit their
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c)

d)

e) f)

g) h)

i)

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Vitamin Policy

recommendations for finalization of formulations in line with b & c. They will also report about the food supplements fate. A comprehensive report will be submitted for final consideration of the Drugs Registration Board. No new registration will be permitted to the Vitamins and Minerals formulations which will not be identical with the formulations in b & c or free sale certificate will be provided from the developed countries.

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